The following data is part of a premarket notification filed by Synergetics, Inc with the FDA for Aynergetics Disposable Spetzler-malis Standard Bipolar Forceps.
| Device ID | K121426 |
| 510k Number | K121426 |
| Device Name: | AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SYNERGETICS, INC 3845 CORPORATE CENTRE DRIVE O'fallon, MO 63368 |
| Contact | Gary Oliveros |
| Correspondent | Gary Oliveros SYNERGETICS, INC 3845 CORPORATE CENTRE DRIVE O'fallon, MO 63368 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-14 |
| Decision Date | 2012-07-10 |
| Summary: | summary |